(90 days)
The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of dark, unwanted body hair.
The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation.
The provided text is a 510(k) summary for the Sharplan Model 5000 Alexandrite Laser System, indicating its clearance for marketing based on substantial equivalence to predicate devices for the removal of dark, unwanted body hair. While it mentions clinical data, it does not provide detailed acceptance criteria or a comprehensive study report in the format requested.
Therefore, much of the requested information cannot be definitively extracted from the provided text. However, I will answer what is available and indicate when information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. It focuses on the device's substantial equivalence to predicate devices and its intended use for hair removal rather than specific metrics like success rate, adverse event rate thresholds, or hair reduction percentages.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Clinical data on 40 subjects was presented." |
| Not specified | "intended for use in dermatology for the removal of dark, unwanted body hair." |
| Not specified | "From both a design and clinical perspective, the predicate and candidate devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Therefore, the Sharplan Model 5000 Alexandrite Surgical Laser should not raise any concerns regarding its overall safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: 40 subjects
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The nature of "clinical data on 40 subjects" for hair removal would typically involve physician assessment, but no details about the number or qualifications of these experts are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not relevant to this device, which is an Alexandrite Laser System for hair removal, not an AI-assisted diagnostic tool involving human readers. Therefore, no such study was done, and no effect size for human readers with/without AI assistance is applicable or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a laser system, not an algorithm. Its performance is inherent to the device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a hair removal device, the "ground truth" would likely be the observed outcome of hair reduction or removal, assessed visually or through other objective measures (e.g., hair count in a defined area). The document only states "Clinical data on 40 subjects was presented," implying that patient outcomes after treatment were evaluated.
8. The sample size for the training set
This information is not provided. The term "training set" is generally used for machine learning models, which is not applicable here. The "clinical data on 40 subjects" likely refers to the pivotal clinical evidence presented for the device, not a training set in the AI sense.
9. How the ground truth for the training set was established
As the concept of a "training set" in the context of AI/machine learning is not applicable here, this information is not provided. If referring to how the "clinical data on 40 subjects" established efficacy, it would be through direct observation of hair removal/reduction results post-treatment, likely by a clinician, but the methodology is not detailed.
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K9733J'4
DEC - 4 1997
S10(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Model 5000 Alexandrite Laser System
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of Sharplan Model 5000 Alexandrite Laser System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which are the Cynosure Alexandrite Laser for Hair Removal and the Sharplan Model 5000 Alexandrite Laser System for Dermatology.
- Sharplan Lasers, Inc. 1. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance August 22, 1997
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- Model: Sharplan Model 5000 Alexandrite Laser System
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- Predicate Devices: The Cynosure Alexandrite Laser (cleared by FDA, August, 1997), and the Sharplan Model 5000 Alexandrite Laser System for Dermatology (K971874)
- Description: The Sharplan Model Alexandrite Laser System is a medical device 4 . which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of an visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation
- The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology 5. for the removal of dark, unwanted body hair. Clinical data on 40 subjects was presented.
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- From both a design and clinical perspective, the predicate and candidate devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Therefore, the Sharplan Model 5000 Alexandrite Surgical Laser should not raise any concerns regarding its overall safety or effectiveness.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is simple and recognizable, conveying a sense of authority and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George J. Hattub Director Regulatory Affairs/Quality Assurance Sharplan Lasers, Incorporated 33 Plan Way Warwick, Rhode Island 02886
DEC = 4 1997
Re: K973354
Trade Name: Sharplan Model 5000 Alexandrite Laser System Regulatory Class: II Product Code: GEX Dated: September 4, 1997 Received: September 5, 1997
Dear Mr. Hattub:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Hattub
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known): 上午73354
Device Name: Sharplan Model 5000 Alexandrite Laser System_
Indications For Use:
The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of unwanted dark body hair.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
bc Deep
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.